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Reporting into the General manager, The Director of Quality & Regulatory will maintain and enhance the current ISO 13485, FDA cGMP and Canadian Medical Devices Conformity Assessment System (CMDCAS), Complaint system, and Quality Management System (QMS). The role is part of the Senior Management team and helps drive day-to-day activities as well as strategic initiatives.
The Quality Manager will be responsible for overseeing the quality assurance and control processes with my client and report into the General Manager of the site. This role involves developing, implementing, and maintaining quality management systems to ensure compliance with industry standards and customer requirements.
The Director of Quality Assurance oversees all quality functions, including engineering, assurance, control, document control, and systems, requiring hands-on involvement in daily operations and improvement projects for globally distributed Class III devices. This role is crucial for maintaining compliance with ISO 13485 and other international regulatory standards.
As the Manufacturing Manager, you will be reporting directly to the Plant Manager of the site, and will be responsible for the Steel Value Stream side of the facility, which produces 1.3 million unites per week in a highly automated manufacturing space. You will oversee 4 Supervisors across 3 shifts and 100 indirect reports.
Our client is seeking to hire an experienced Director of Operations to lead the development and implementation of the company's operational and strategic engineering goals. The Director of Operations will supervise operations/engineering, production and quality teams and the expansion of the business' proprietary intellectual property portfolio.
The Health, Safety & Environmental Manager oversees all safety, health, environmental, and security activities to ensure compliance with federal, state, local regulations, and company policies, working proactively to eliminate workplace risks and hazards while providing adequate training for employees. They also make recommendations for program improvements and collaborate with facility management to meet safety and environmental goals.
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